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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K211989
Device Name Aveir Introducer
Applicant
Abbott Medical
15900 Valley View Court
Sylamr,  CA  91342
Applicant Contact Bijal Jain
Correspondent
Abbott Medical
15900 Valley View Court
Sylamr,  CA  91342
Correspondent Contact Bijal Jain
Regulation Number870.1340
Classification Product Code
DYB  
Date Received06/28/2021
Decision Date 07/27/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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